Approval · Notice of Compliance 4810 · 1995
PROLASTIN: Notice of Compliance 4810
Issued November 30, 1995
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 4810
- Date
- November 30, 1995
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes in manufacturing
- Therapeutic class
- Alpha1 - antitrypsin replenisher
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLASTIN | 00803529 | Cancelled Post Market |
| PROLASTIN | Not yet assigned | — |
Medicinal ingredients
- ALPHA1-PROTEINASE INHIBITOR (HUMAN) 500 MG per VIAL
- ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1,000 MG per VIAL